Appeal No. 1997-1842
Application 08/068,878
15. Lepor 1992 reported the results of a two-year clinical trial of terazosin for the
treatment of symptomatic BPH. Forty-five normotensive patients with symptomatic
BPH were initially given 1 mg/day of terazosin. The dose was subsequently increased
to 5 mg/day over an interval of one month. The patients were maintained on 5 mg of
terazosin throughout the remainder of the study. Twenty-one patients continued the
two year study. The remainder of the patients were excluded because of adverse drug
reactions, slight or no clinical response, deterioration of clinical response, lack of
compliance, etc. Page 1554, column 1, second paragraph, through page 1555,
column 3, line 31.
16. Lepor 1992 reported that the obstructive and irritative symptom scores
decreased by 63% and 65%, respectively, after two months of terazosin therapy. The
improvements in obstructive and irritative symptom scores were maintained throughout
the two-year follow-up. The peak and mean urinary flow rates improved by 42% and
48%, respectively, after two months of terazosin therapy. The changes in mean urinary
flow rate increased, whereas the changes in peak urinary flow rate decreased during
the follow-up. Page 1555, column 1, first and second paragraphs; page 1556,
column 2, lines 1-15; Figures 1 and 2.
17. Lepor 1992 disclosed that their study underestimates the efficacy of
terazosin since a maximal therapeutic dose was not administered. Lepor 1992
disclosed that a randomized placebo-controlled study, not yet published, compared a
10
Page: Previous 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Next
Last modified: November 3, 2007